title: Recombinant streptokinase suppositories in the treatment of acute haemorrhoidal disease. Multicentre randomized double-blind placebo-controlled trial (THERESA-2).
abstract: OBJECTIVE
  A four-arm multicentre randomized double-blind placebo-controlled trial was undertaken to assess the effect and safety of suppositories containing recombinant streptokinase (rSK) at two dose levels (100,000 IU and 200,000 IU) with sodium salicylate (SS) compared with placebo and SS for the treatment of acute haemorrhoidal disease.
  
  
  METHODS
  Patients with acute symptoms of haemorrhoids were randomized to four treatment groups: (I) placebo, (II) SS, (III) SS + rSK 100,000 IU and (IV) SS + rSK 200,000 IU per suppository. Inpatient treatment was by four suppositories given every 6 h to discharge at 24 h. Evaluations were made at the time of discharge (24 h) and at 3, 5 and 20 days later. The main end-point was the degree of relief of pain, oedema and reduction in the size of the lesion by 90% on day 5. Adverse events and the occurrence of anti-SK antibodies were also determined.
  
  
  RESULTS
  Eighty patients were included. Respective response rates in the four groups were 16%, 30%, 25% and 52%. In the last group there was a significant difference (36.8%) compared with control (95% CI 7.0-58.4%). The time to response was significantly shorter (median 5 days) in the 200,000 IU rSK group with respect to the others. There were no adverse events attributable to the treatment. No increase in anti-SK antibodies was detected 20 days after treatment.
  
  
  CONCLUSIONS
  Suppositories with 200,000 IU rSK showed a significant improvement in symptoms of acute haemorrhoids, with an adequate safety profile.
authors.affiliation: Centre for Genetic Engineering and Biotechnology, Havana, Cuba.
authors.forename: F
authors.initials: F
authors.lastname: Hernández-Bernal
authors.forename: C M
authors.initials: CM
authors.lastname: Valenzuela-Silva
authors.forename: L
authors.initials: L
authors.lastname: Quintero-Tabío
authors.forename: G
authors.initials: G
authors.lastname: Castellanos-Sierra
authors.forename: D
authors.initials: D
authors.lastname: Monterrey-Cao
authors.forename: A
authors.initials: A
authors.lastname: Aguilera-Barreto
authors.forename: P
authors.initials: P
authors.lastname: López-Saura
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004487:Edema / Q000209:etiology; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006484:Hemorrhoids / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D010147:Pain Measurement; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012980:Sodium Salicylate / Q000008:administration & dosage; D013300:Streptokinase / Q000008:administration & dosage* / Q000009:adverse effects; D013488:Suppositories / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D005343:Fibrinolytic Agents; D011994:Recombinant Proteins; D013488:Suppositories; D013300:Streptokinase; D012980:Sodium Salicylate
keywords: Streptokinase suppository; acute haemorrhoidal disease; thrombolysis